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FDA PRODUCT CODE · CLASS I

PNA — Evoked Photon Image Capture Device

The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin.

DEVICE CLASS
Class I
REGULATION
21 CFR 882.1561
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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